The PositionThis position resides within the Integrated Quality Operations function under the Quality organization. The Quality Operations Investigation Lead serves as the Quality Assurance subject matter expert for nonconformance management across GMP operations, supporting programs from early phase clinical development through late phase and commercial production. The position partners with QMS record owners across Manufacturing, Quality Control, Analytical Development, Supply Chain, Facilities and Engineering, and external partners to ensure that deviations, nonconformances, OOS/OOT and atypical results, CAPAs, and associated change control records are investigated thoroughly, documented accurately, and closed on time. These activities span raw materials, in-process manufacturing, environmental monitoring, drug substance and drug product, packaging and labeling, storage and distribution, and stability, with phase-appropriate GMP expectations applied as programs progress toward commercial supply. The Investigation Lead serves as the primary Quality Assurance representative for investigation-related activities, guiding and coaching record owners rather than owning the records on their behalf.
Responsibilities
- Serve as the Quality Assurance subject matter expert for GMP nonconformance management across early phase clinical, late phase, and commercial operations.
- Partner with QMS record owners across functions to initiate, progress, and close deviations, nonconformances, OOS/OOT and atypical results, CAPAs, and associated change controls, coaching owners on investigation structure, evidence collection, and documentation expectations.
- Ensure the timely completion of high quality, robust GMP investigations with clearly defined and scientifically sound root cause determination.
- Guide record owners through, and where needed personally lead, structured science-based root cause analysis (RCA) using approved methodologies (5-Whys, Ishikawa, Fault Tree, etc).
- Review and approve investigation records as the Quality Assurance subject matter expert/reviewer, challenging conclusions and verifying the scope of impact, product impact, and assessment of other affected batches, materials, and programs are complete and justified.
- Develop, justify, and oversee the implementation of effective Corrective and Preventative Actions (CAPAs) to prevent recurrence, and evaluate effectiveness checks at closure.
- Apply phase-appropriate expectations to investigations, ensuring that investigation depth, documentation, and CAPA rigor scale appropriately as programs progress from early phase clinical material through validated commercial production.
- Provide timely investigation conclusions and product impact assessments to support material and batch disposition decisions.
- Escalate events to management when they represent potential significant quality risks or may impact investigation closure timelines or product release.
- Evaluate historical data, trends and prior investigations for recurrence or systemic issues and opportunities for proactive improvement, and support periodic quality event trending and reporting.
- Support the maintenance and improvement of investigation compliance metrics, including on-time closure, record aging, extension rates, and right-first-time record quality.
- Support quality events arising at external partners, including CDMOs/CMOs and contract testing laboratories, as assigned and in coordination with the external partner oversight owner.
- Support regulatory inspections and internal/external audits by maintaining inspection readiness and serving as a subject matter expert (SME) for the nonconformance, investigation, and CAPA processes.
- Participate in and contribute to continuous improvement initiatives related to the investigation and CAPA processes.
- Contribute to site Quality Operations compliance activities in alignment with Arrowhead standards, procedures and cGMP requirements.
- Collaborate cross functionally with site personnel to provide guidance and drive resolution of end-to-end manufacturing and quality issues, working independently while partnering effectively with Manufacturing, Quality Control, Analytical Development, Supply Chain, Project Management, and external partners.
- Ensure accurate, complete, and timely documentation and review of investigations, CAPAs, change controls, and complaints within the electronic quality management system.
- Maintain knowledge of current compliance expectations and regulations pertaining to investigational and commercial products (e.g., 21 CFR Parts 210 and 211, ICH Q7, Q9, and Q10, and EU GMP and applicable Annexes).
- Additional duties as assigned.
Requirements- Bachelors Degree in Chemistry, Biology, Engineering, or a related scientific field
- 5+ years of GMP experience in the pharmaceutical or biotechnology industry, including direct experience authoring, reviewing, or approving deviations, investigations, and CAPAs. Preferably a candidate with working experience in pharmaceutical and/or oligonucleotide manufacturing.
- Knowledge of cGMP and GDP, ICH and FDA/EU guidance.
- Demonstrated experience applying structured root cause analysis methodologies to GMP investigations.
- Working knowledge of manufacturing and laboratory operations sufficient to evaluate technical investigations, including familiarity with analytical instrumentation (e.g., HPLC, GC, LC-MS, KF, FTIR, endotoxin plate readers, pH, osmolality and/or Raman) and manufacturing unit operations.
- Demonstrated ability to influence, guide, and hold accountable record owners who are not direct reports.
- Great attention to detail and ability to follow procedures.
- Ability to work in GMP manufacturing and laboratory areas, including meeting applicable gowning requirements.
Preferred
- Experience supporting GMP operations across both early phase clinical and commercial production, including application of phase-appropriate GMP.
- Experience with oligonucleotide, peptide, or biologic modalities and/or sterile drug product.
- Formal training in root cause analysis and human error reduction methodologies.
- Excellent organizational skills with the ability to simplify and clearly communicate complex quality and technical concepts.
- Excellent verbal, written, and presentation skills, including the ability to clearly articulate investigation outcomes, risk assessments, and decisions.
- Demonstrated ability to interpret quality issues and determine scientifically sound, compliant resolutions that minimize risk and withstand regulatory scrutiny.
- Strong ability to collaborate effectively with stakeholders, customers, and peers to drive timely resolution of quality issues across the product lifecycle.
- Proven decision-making capability, with the ability to think critically and creatively while maintaining compliance, quality standards, and GMP expectations.
- Ability to assess the criticality of quality issues and clearly communicate complex risks, trends, and investigation outcomes to management.
- Demonstrated understanding and application of ICH Q10 Pharmaceutical Quality System principles, including risk management, CAPA effectiveness, knowledge management, and continuous improvement across the product lifecycle.
- Capability to support and maintain a state of inspection readiness through accurate, complete, and traceable documentation aligned with cGMP and data integrity expectations.
- Proficiency in Microsoft Office Suite and QMS systems such as Veeva and experience with LIMS.
Wisconsin pay range
$90,000-$105,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
